New age Hepatitis C medicines are more than just a medical wonder. They gave humanity an ability to save lives.
How good are we at saving those lives?
Hepatitis C is a serious disease that ultimately results in death of patients. Approximately 500,000 people die from Hepatitis C and related illnesses in 2013 alone, more than 20,000 of them were US citizens. To put it in perspective: HIV/AIDS has longed been talked about as a very serious disease with a disastrous death toll. However, according to Dr. Laura J. Martin of WebMD nowadays more people die from Hepatitis C than from HIV/AIDS.
Today, there are more than 3.2 million of Hepatitis C patients in the US alone.
In late 2013, however, humanity had a break-through that should by all accounts drastically change lives of people living with Hepatitis C. A new drug, Sovaldi (400mg sofosobuvir), was approved in December 2013 on the US market.
With it, more than 90% of people with Hepatitis C can be cured. But are they really being cured?
For any disease to be deemed a very problematic one, there are two conditions:
Polio, for example, was a very serious disease with a disastrous outcome. However, after discovering an efficient polio vaccine, the number of patient and number of death relating to polio was reduced dramatically.
Hepatitis C prior to 2013 was a very problematic disease because it caused death via liver cirrhosis and liver cancer, and the only treatment we had was 50% efficient.
Hepatitis C patients were put on 6-months long interferon-based treatment which consisted of injecting oneself with interferon and taking additional oral medicines such as ribavirin (antiviral molecule). Nonetheless, for 1 out of every 2 patients treated the treatment has been proven to be unsuccessful.
There was a need for an efficient cure. Newly-discovered sofosbuvir molecule was the answer.
With the launch of Sovaldi and Harvoni medicines by a company Gilead Sciences, humanity finally attained a very effective cure for Hepatitis C. Being an all-oral regimen, sofosbuvir pills are taken on a daily basis for 12-weeks (standard treatment), have mild side effects and, above all, more than 95% cure rate. This is what in pharmaceutical industry refer to as a game-changer. Now almost everyone can be cured and Hepatitis C suddenly became an easily curable disease.
Simple answer is 'YES'. While the number of deaths has decreased from 500,000 per year, there are still hundreds of thousands of people dying every year. The reason: Hepatitis C.
But if we know Hepatitis C is so easily treatable nowadays, why are people still dying?
When we spoke about Harvoni and Sovaldi being a game-changer in industrial industry, it was meant more in profits than in saving lives. Here are two simple reasons why people even in the developed world are still dying of Hepatitis C.
With this in mind, let us calculate the US Hepatitis C market. If we know there are 3,2 million Hepatitis C patients, each in need of an $80,000 cure, the total comes to staggering number: Gilead Sciences is looking to sell more than $250 billion worth of Hepatitis C medicine to patients who can die without it.
Here is a horrifying realization. We have people who will die without the cure. We have the cure. But people who are dying cannot afford the cure because it is priced extremely high. 'What have we come to as a society?' is the right question here.
Gilead Sciences, company that markets Sovaldi and Harvoni, offered licences to Indian manufacturers to produce generic version of sofosbuvir-based medicines. In short, India refused to recognise a level of innovation for sofosbuvir molecule that would grant Gilead Sciences a patent and monopoly over Hepatitis C market in India.
This created a loophole. This loophole is now saving lives.
All around the world there are Hepatitis C patients that will die without getting the cure - and they are not getting it because the prices of the drugs are so extremely high. This is where FixHepC Buyers Club comes in.
It is our mission to deliver life-saving Hepatitis C medicines to your doorstep for a negligible cost. We have set up a supply chain consisting of sofosbuvir production, packaging and distribution across the world. It is our hope this will bring down the Hepatitis C death toll under 100,000 and that in near future Hepatitis C death cases will be as few in number as possible with sofosbuvir-based medication.
We strive to deliver generic Harvoni anywhere on the planet for less than $2,000 per treatment in about 2-3 weeks. With this prices, we could cure all Hepatitis C patients in the US for less than $7 billion.
Hardly. Pharmaceutical industry holds on to patents for drugs that last for 20- to 25-years. During this time, the prices of original Sovaldi and Harvoni will be extremely high, and Hepatitis C patients don't have 20 or more year to wait for patents to expire.
The thing with Hep C is that it's not about anonymous statistics, it's about real people. Here's the story of one patient, and his wife's journey through Interferon and failure and then to self initiated treatment and cure via the parallel import of generic DAA medications that was published in the Sydney Morning Herald and The Age:
Here is a letter to the editor that did not make the cut
Sunday 27th September 2015
(Ref: Hepatitis C drug buyers club aims to set up new source of support)
In 1961 JFK uttered the immortal lines "ask not what your country can do for you - ask what you can do for your country".
With the passage of time, the idea we should all put something back in seems increasingly lost.
We have at our fingertips the tools to rid the world of Hepatitis C and are separated from that only by corporate avarice.
Gilead Sciences are asking for more than the entire annual PBS medications budget, used to treat all Australians for all diseases, to treat a single disease forecast to kill half as many people as breast cancer by 2030.
If this medication pricing trend continues unabated you can foresee the day we invent a cure for cancer, but people still die because only a fortunate few can afford access.
Parallel importing is a tool that has been used before to level the playing field, most notably around the pricing of HIV medications. $1000 a tablet for something that costs $1 to produce and is available overseas for $10 does not make sense.
It’s time to draw a line in the sand and make it clear patient rights deserve equal protection to patent rights.
Dr James Freeman
A patient posted a link that contained a powerpoint presentation from Dr Andrew Hill, PhD. I asked Dr Hill if I could post it here and he said yes.
I turned that into a very quick YouTube movie, so you will probably have to pause it to read it. The attachments include the original PPT (and a PDF version) and two recent papers. Use the readmore to get to them.
Hepatitis Australia is using new data released from the Kirby Institute today showing only one per cent of people with hep C received treatment last year to push the government to list new hep C drugs without delay.
"It's time for action," said Kevin Marriott, Hepatitis Australia Acting CEO. "It's time of the federal government to make new therapies widely available, increase liver clinic capacity, upscale hepatitis C treatment and prevention programs and transform the lives of thousands of Australians."
New surveillance data from the Kirby Institute estimated some 230,470 people had chronic hepatitis C infection at the end of 2014. Around 80 percent had early to moderate fibrosis and 19 percent had severe fibrosis or hepatitis C related cirrhosis.
The estimated number of people with severe liver disease/hepatitis C related cirrhosis has more than doubled in ten years, according to the data.
Head of the viral hepatitis clinical research program at the Kirby Institute Professor Greg Dore said that without significant improvement in hepatitis C treatment rates, Australia would see a 245 percent increase in the rates of liver cancer and 230 percent increase in hep C-related deaths by 2030.
"Thousands of Australians are queuing up waiting for new medicines to be PBS listed. These treatments provide one of the great breakthroughs in clinical medicine in recent decades, with enormous potential to improve the lives of people living with hepatitis C," Professor Dore said.
Four new hep C medicines - Gilead's Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir), BMS's Daklinza (daclatasvir)and AbbVie's Viekira Pak (paritaprevir with ritonavir, ombitasvir and dasabuvir plus ribavirin) - have been recommended for PBS listing but price negotiations with sponsors are ongoing. Professor Dore said previously, he suspected listing is more likely for sometime in 2016.
Mr Marriott said there is compelling evidence for the new medicines to be listed without delay before people progress to serious liver disease and die.
"Interferon-free therapies will allow the vast majority of people living with the hepatitis C virus to be cured, even where treatment has failed previously and without the terrible side-effects of existing treatments."
Originally published in Pharma in Focus. Reproduced with permission.
Today we compared a new batch of Sofosbuvir and Ledipasvir to our reference sample data and found it consistent.
It's reassuring to see the consistency.